Reported Sep 16, 2026 · Ongoing
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc.,…
Ajanta Pharma USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ajanta Pharma USA Inc · 400 Crossing Blvd Ste 102 · Bridgewater, NJ · 08807-2863
Is this the product you have?
- Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only
- Marketed byAjanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01
- Lot codes and dates
Lot #: DJ23254Exp. Date 11/30/2026DJ10205Exp. Date 04/30/2027
- Amount recalled
- 403,200 tablets
Where it was sold
- Nationwide
Why it was recalled
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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